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U.S. Department of Health and Human Services

Class 3 Device Recall GE Centricity Laboratory Software

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  Class 3 Device Recall GE Centricity Laboratory Software see related information
Date Initiated by Firm May 26, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on July 15, 2011
Recall Number Z-2067-2010
Recall Event ID 55868
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.

Code Information All versions and releases
Recalling Firm/
Manufacturer		 Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		 There is a potential safety issue associated with the use of GE Centricity Laboratory software where results from interfaced external reference laboratories are not displayed or stored correctly. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the test result sent from the reference lab includes a comma in the result field.
FDA Determined
Cause 2		 Software design
Action The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated May 26, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue involving results from interfaced external reference laboratories that are not displayed or stored correctly if an unexpected alpha character is encountered in a result message that is expected to have a numeric value. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the result sent from the reference lab includes a comma in the result field. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to the their GE Service Representative or the GE Helpdesk at 888-778-3375.
Quantity in Commerce 37 units
Distribution Worldwide distribution: California, Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee and Texas, and internationally to Australia, Canada, China, England, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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